Team:Evry Paris-Saclay/HP/Annexe/Maxime

IGEM Evry Paris-Saclay

Legal Investigation

In France as in many countries, research is important for development. It leads to new markets, new technologies, and allows the country to compete internationally. To do so, and to facilitate ease of research in France, the French and European legislation removed almost all regulatory barriers to research. These barriers were specifically designed to regulate the impact of GMOs on the environment (articles L241-1 to L241-3 of the Environment Code), animal research (articles L231-1 to L231-2 of the Research Code) and finally to regulate research on humans (articles L1121-1 to L1126-11 of the Public Health Code and articles L221-1 to L221-3 of the Research Code).

Therefore, within the scale of our project, our choices concerning the bioscreening of psicose producing enzymes have been free of any regulations (article 19 of the Universal Declaration of Human Rights and 10 of the European Convention of Human Rights).

However, we didn’t want to stop there. We wanted to determine, based on legislation, how it would be possible to bioproduce Psicose and put it on the European market. At the moment it is not available on the French market, nor in Europe. To understand the legislative mechanism required to put it on the market, we researched the relevant legislation and contacted national and European institutions. Firstly, we had to determine in which food category Psicose belongs. We call this legislative qualification. French legislation is heavily influenced by European legislation and especially European regulations. According to regulations n° 1331/2008 and 178/2002, Psicose belongs to the category of “food additives” and more specifically the category of “sweeteners”. Regulation n°1331/2008 entered into force in January 2010. According to this regulation, a sweetener can substitute sugar only if it fulfils certain conditions.

The legislative qualification is important. After determining that psicose is a sweetener, we had to exclude the qualification of psicose as a medicine. The qualification of medicine in France and the EU is very restrictive and has a lot of obligations for the producer (article L5111-1 of Public Health Code). We didn’t want psicose to be qualified as a medicine. According to the first article of Directive 2001/83/EC of the European Parliament, a medicine is “Any substance or combination of substances presented for treating or preventing disease in human beings”. According to this definition, to avoid the qualification of medicine psicose shouldn’t sold as a cure or treatment for diseases such as diabetes. In addition researchers should thoroughly determine the physiological effects of the product containing psicose and according to their composition, the qualification of sweetener or medicine will be revealed. For example, a vitamin isn’t a medicine when it’s used in a low rate (composition) - decision of the criminal chamber of the court of cassation, 21st of January 2014, number of decision : 13-80.112.

Secondly, we had to determine, the regulatory process required to put a food additive on the European and French markets. To be authorized on the national market, it needs to be authorized on the European market. To do so, the European Commission, more specifically its “Health and Food Safety Department”, needs to authorize its placing on the market based on many criteria. The food additive shall not be harmful to health, nor pose risks for consumer safety and it must respond to a reasonable need which cannot be solved by any other means. To proceed with the authorization the European Commission needs a scientific opinion from the European Food Safety Authority (EFSA). This authority is composed of scientists who will debate the safety and health aspects of the food additive. To do so, the applicant must provide the following information (link to the document Jason did). After giving its opinion, the European Commission will authorize or not the food additive. When authorized, the food additive will be added to the “food additive authorized list” (regulations 1129/2011 and 1130/2011).

Once authorized on the European market, the food additive must be authorized at the national level. The member states regulators will determine if they want to authorize the food additive or not. However according to articles 34 and 36 of the Treaty on the Functioning of the European Union (TFEU), once a product is authorized and put on the market of the member State, the other member States cannot oppose the circulation of the product on their markets even though they themselves did not authorize the commercialisation of the product.

In France and according to the decision of the European commission, l’ANSES (the national agency of health food security, environment security and work security) will monitor the food additives authorized by the European Commission. This agency will follow the same criteria on which the EFSA based its opinion such as the toxicology of the product, the impact on human health, and its potential therapeutic benefits. This follow up is not mandatory and ANSES itself decides which food additive it wants to follow up. To ensure the economic rules are respected, the DGCCRF (Directorate-General for Competition, Consumer Affairs and Prevention of Fraud) will give its opinion. On the regional level DIRECCTE (regional directorate for competition, companies, consumption, work and employment) has the ability to control market competition and will regulate anti-competitive conduct. However, it can only control the product once it has been authorised.

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